David N. Muchemu
Instructor David N. Muchemu
Product Id 600425
Duration 60 Minutes  
Version Recorded
Original Price $295
Special Offer Price $10
Refund Policy
Access recorded version only for one participant; unlimited viewing for 6 months

Off-Label Promotion of Medical Devices: Maximizing Your Performance Claims within FDA's Framework of Acceptable Practices

Overview:

The webinar covers "Off-label statute" and the FDA's nonbinding off-label guidance as relates to re-prints, performance claims, and Promotion.

Emphasis is placed on ethical, moral, and legal expectations from the FDA. You will improve your understanding of regulatory expectations for your products and improve promotional compliance for released products. The webinar is designed to help attendees understand the "off-label statute" and its legal implications. It is is also designed to help attendees operate within off-label promotional guidance, or framework.

It is illegal to market a device for the purpose that it has not been approved for by the FDA. This webinar provides guidelines set by the FDA for off-label promotion.

Areas Covered in the Session:

  • Off-label statute
  • Label claims
  • Allowable reprints
  • Promotional compliance
  • FDCA: The law

Who Will Benefit:
  • Sales executives in Medical Device
  • Regulatory Affairs personnel
  • Executives
  • Corporate counsel
  • Quality personnel
  • Directors

Speaker Profile
Mr. Muchemu has over fifteen years experience in Medical Device, Pharmaceutical, Biomedical and Tissue industries as CAPA Training Instructor, Process validation Instructor, Change control Instructor, and CGMP consultant. He has held major positions at Abbott labs, Genentech, Boston Scientific, and Johnson and Johnson. He holds degrees in Biology, Chemical Engineering, and is currently working an MBA with a concentration in Public Health. He is an established author of several GMP books.

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